N-Acetylcysteine and Milk Thistle for Treatment of Diabetic Nephropathy (CGDN)

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Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

213 subjects met the inclusion criteria on screening from 2 clinic locations: VA and University Hospital Renal clinics.Many had exclusion criteria and few refused to participate. 108 subjects finally enrolled in the study.

Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

During Run-in phase before randomization to the experimental arms, 4 subjects were excluded due to hospitalization for various reasons and 26 were excluded due to issues with transportation or sickness in the family or themselves.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.